1. Publications Ethics Vidya Mave, MD, MPH & TM
Clinical Research Site Leader and Director,
BJ Medical College Clinical Trials Unit, Pune

2. Objectives To review case studies of publication misconduct
To introduce COPE
To discuss few violations and measures to curb misconduct
Concept of “Ghostwriters”

3. Case Study 1: Kenneth Melmon
Stanford University investigated allegations of academic misconduct that have been leveled against the chairman of the Department of Medicine, Kenneth Melmon. The allegations stem from the fact that Melmon incorporated large chunks of copyrighted material from a book he helped edit into a chapter he wrote for another textbook. The material was used without attribution and apparently without permission….
Source: Science. 1984; 224:36-37.

4. What does this constitute?
“Melmon says that when he cut-and pasted the material into his manuscript, he added handwritten notations detailing where the text came from. These notations were supposed to have been printed in the body of his chapter…..”
What does this constitute?
Source: Science. 1984; 224:36-37.

5. Case Study 2: Dr R B Singh (BMJ 2005;331:281-8)
9 papers submitted : diet & M.I.
Doubts raised about truth of data due to discrepancies in subsequent data
Author stated raw data ‘eaten by termites.’
Institution owned by his relatives
Problem: ?Fabricated data

6. Case Study 3: RK Chandra BMJ 2005;331:288–91
Chandra’s paper was submitted originally in 2000 to the BMJ, which had severe doubts about the paper:
One reviewer said that the paper “had all the hallmarksof having been entirely invented.”
The BMJ asked Chandra’s employers—the Memorial University of Newfoundland—to investigate its anxieties about the study. The university held an inquiry but found no serious problem. The BMJ was unconvinced by this response and raised further questions about the study.
In August 2002 the university answered that Chandra had taken unpaid leave for the first four months of 2002 and failed to respond to any of its inquiries, including a request for raw data.
Problem: ? fabricated data, authorship issues

7. Why research and publish
The object of research is to extend human knowledge beyond what is already known.
But an individual’s knowledge enters the domain of science only after it is presented to others in such a fashion that they can independently judge its validity.
(National Academy Press,Washington D C “On Being a Scientist” 1995)

8. Publications in peer reviewed journals
“Science is a shared knowledge based on a common understanding of some aspect of the physical or social world” (NAP, “On Being a Scientist” 1995)
Presentations
- Social conventions play an important role in establishing the reliability of scientific knowledge
Publications in peer reviewed journals
- Research results are privileged until they are published
Thesis
(National Academy Press,Washington D C “On Being a Scientist” 1995)

9. “A paper is an organized description of hypotheses, data and conclusions, intended to instruct the reader. If your research does not generate papers, it might just as well not have been done” (G. Whitesides, Adv. Mater., 2004, 16, 1375)
“if it wasn’t published, it wasn’t done” - in E.H. Miller 1993

10. Motives for scientific misconduct
Funding and career pressures of the contemporary research environment.
Inadequate institutional oversight.
Inappropriate forms of collaborative arrangements between academic scientists and commercial firms.
Inadequate training in the methods and traditions of science.
The increasing scale and complexity of the research environment, leading to the erosion of peer review, mentorship, and educational processes in science.
The possibility that misconduct in science is an expression of a broader social pattern of deviation from traditional norms.
National Academy of Sciences 1992

11. Today’s world Thousands of journals Demand for manuscripts
Competitive world
Demands results
Promotion potential

12. COPE
The Committee on Publication Ethics (COPE) was established in 1997 by a small group of medical journal editors in the UK but now has over 6000 members worldwide from all academic fields.
Membership is open to editors of academic journals and others interested in publication ethics.

13. Why did COPE start?
A growing appreciation of problems around scientific integrity
A series of high profile scandals
The loneliness of editors
The feeling that editors needed to put our house in order
Editors couldn’t wait for the establishment

14. What are the aims of COPE?
To advise on cases brought by editors
Publish an annual report
Publish guidance on the ethics of publishing
Promote research into publication ethics
Offer teaching an training

15. COPE - first 128 cases

16. Let us discuss the 3 of the following
Authorship
Redundant publication
Plaigiarism

17. Supply of patient data, reagents, biological specimens, illustrations
Please review and answer whether the following scenarios constitute authorship? Yes/ No
Supply of patient data, reagents, biological specimens, illustrations
Co-ordination or participation in the collection of data
Care or examination of patients
Supply of funds or space
Technical work in the laboratory
Head of department or institute

18. What constitutes authorship
International committee of medical journal editors (ICMJE) has set guidelines
“Authorship credit should be based only on
1) substantial contributions to conception and design, or acquisition of data, or analysis and interpretation of data;
2) drafting the article or revising it critically for important intellectual content; and
3) final approval of the version to be published.
Conditions 1, 2, and 3 must all be met. “

19. When a large, multicenter group has conducted the work, the group should identify the individuals who accept direct responsibility for the manuscript.
These individuals should fully meet the criteria for authorship/contributorship defined above, and editors will ask these individuals to complete journal-specific author and conflict-of-interest disclosure forms.
When submitting a manuscript authored by a group, the corresponding author should clearly indicate the preferred citation and identify all individual authors as well as the group name. Journals generally list other members of the group in the Acknowledgments.
The NLM indexes the group name and the names of individuals the group has identified as being directly responsible for the manuscript; it also lists the names of collaborators if they are listed in Acknowledgments.

20. Acquisition of funding, collection of data, or general supervision of the research group alone does not constitute authorship.
All persons designated as authors should qualify for authorship, and all those who qualify should be listed.
Each author should have participated sufficiently in the work to take public responsibility for appropriate portions of the content.

21. Author contributions

22. Have you heard about “Ghostauthors”?
Unnamed/ uncredited author writes manuscript
Official authorship/attribution given to someone else
Actual writer never mentioned on article
Often refers to professional or staff writers sponsored by pharmaceutical/device company
whose names are not listed on article
Prominent doctors/scientists in field often listed as authors, whether or not they were involved with the study
Sullivan, D et al. volume127, No.6

23. Problems associated with ghost authorship
Industry-sponsored writers can introduce bias that may affect doctors and patient care
Seen as “the failure to designate an individual (as an author) who has made a substantial contribution to the research or writing of a manuscript”
Viewed as a major problem in academic medicine, pharmaceutical industry, and biomedical publishing

24. Redundant publication
Publication of a paper that overlaps substantially with one already published in print or electronic media.
Unethical
Wastes time of peer-reviewers and editors
Wastes resources and Journal pages
Leads to flawed meta analysis
Distorts Academic reward system
Infringes on copyright
Inflates scientific literature for no benefit other than to author

25. Among the principal considerations that have led to this policy are:
Not to be confused with duplicate publications (simultaneous submission)
Most biomedical journals will not consider manuscripts that are simultaneously being considered by other journals.
Among the principal considerations that have led to this policy are:
1) the potential for disagreement when two (or more) journals claim the right to publish a manuscript that has been submitted simultaneously to more than one; and
2) the possibility that two or more journals will unknowingly and unnecessarily undertake the work of peer review, edit the same manuscript, and publish the same article.

26. Certain types of articles, such as guidelines produced by governmental agencies and professional organizations, may need to reach the widest possible audience. In such instances, editors sometimes deliberately publish material that is also being published in other journals, with the agreement of the authors and the editors of those journals.

27. Prevention Better education on publication guidelines and ethics.
Introduction of registers for planned and on-going clinical trials.
Change criteria from quantity to quality when papers are used for assessment of posts or grants.

28. What is Plaigiarism (www.plaigiarism.org)
According to the Merriam-Webster Online Dictionary, to "plagiarize" means
to steal and pass off (the ideas or words of another) as one's own
to use (another's production) without crediting the source
to commit literary theft
to present as new and original an idea or product derived from an existing source.
In other words, plagiarism is an act of fraud. It involves both stealing someone else's work and lying about it afterward.

29. Are the following plaigiarism? Yes/ No
Turning in someone else's work as your own
Copying words or ideas from someone else without giving credit
Failing to put a quotation in quotation marks
Giving incorrect information about the source of a quotation
Changing words but copying the sentence structure of a source without giving credit
Copying so many words or ideas from a source that it makes up the majority of your work, whether you give credit or not (

30. Prevention
Most cases of plagiarism can be avoided, however, by citing sources.
Simply acknowledging that certain material has been borrowed, and providing your audience with the information necessary to find that source, is usually enough to prevent plagiarism. (

31. Conflict of interest (www.icmje.org/ethical_1author.html)
Conflict of interest exists when an author (or the author’s institution), reviewer, or editor has financial or personal relationships that inappropriately influence (bias) his or her actions (such relationships are also known as dual commitments, competing interests, or competing loyalties).
These relationships vary from being negligible to having great potential for influencing judgment.
Not all relationships represent true conflict of interest. On the other hand, the potential for conflict of interest can exist regardless of whether an individual believes that the relationship affects his or her scientific judgment.
Financial relationships (such as employment, consultancies, stock ownership, honoraria, and paid expert testimony) are the most easily identifiable conflicts of interest and the most likely to undermine the credibility of the journal, the authors, and of science itself.

32. Prevention
Authors must state explicitly whether potential conflicts do or do not exist.
Authors should do so in the manuscript on a conflict-of-interest notification page that follows the title page, providing additional detail, if necessary, in a cover letter that accompanies the manuscript.

33. Authors should identify individuals who provide writing or other assistance and disclose the funding source for this assistance.
Investigators must disclose potential conflicts to study participants and should state in the manuscript whether they have done so.
Editors also need to decide whether to publish information disclosed by authors about potential conflicts. If doubt exists, it is best to err on the side of publication.

34. Thank you.
Any questions?

35. Resources www.publicationethics.org/ resources www.icmje.org
Acknowledgements:
Presentations of Hooman Momen, WHO bulletin editor,
The work of COPE by Mike Farthing, editor, GUT, Richard Horton, editor, Lancet, Richard Smith, editor, BMJ, Alex Williamson, publishing director, BMJ Publishing Group